A medical device consulting company working with medical device manufacturers around the world

5523 Research Park Drive, Suite 205, Baltimore, MD   410.674.2060

CardioMed Device Consultants, LLC

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 President and Founder - H. Semih Oktay, PhD

 

MEET OUR STAFF

PRESIDENT AND FOUNDER

    red01_next.gif H. Semih Oktay, PhD

 

HONORARY VP, ENGINEERING

    red01_next.gif Daniel J. Chwirut, MS, PE

 

PRINCIPAL CONSULTANTS

    red01_next.gif Judith J. Danielson, RN, BSN, MPH

    red01_next.gif Richard E. Galgon, MD, MS

    red01_next.gif Elisa D. Harvey, DVM, PhD

    red01_next.gif Stephen L. Hilbert, PhD, MD

    red01_next.gif Mona M. Advani, BS, MS, MBA

    red01_next.gif Candace F. Cederman, MS

    

AFFILIATE CONSULTANTS

    red01_next.gif Jodell D. Kause, BS, RAC

    red01_next.gif Wenda C. Carlyle, PhD

    red01_next.gif Anna Christensen

    red01_next.gif Sherry L. Sparrow, BA

    red01_next.gif Brian Cleary, MS

    red01_next.gif Patrick J. Marroum, PhD

 

CLINICAL SERVICES CONSULTANTS

    red01_next.gif Victor Novack, MD, PhD

    red01_next.gif Jessica Boyle, BS, MSc

Semih Oktay is the President and founder of CardioMed Device Consultants.  Prior to founding CardioMed, he was Vice President of Regulatory Affairs and Engineering at MicroMed Laboratories, Inc (Petaluma, CA).  In this capacity, Dr. Oktay provided engineering and regulatory consulting services to the medical device and related industries, and managed MicroMedís east-coast office.

Prior to joining MicroMed, Dr. Oktay worked for six years as an expert mechanical engineer and scientific reviewer for the U.S. Food and Drug Administration (FDA) in the Office of Device Evaluation, Interventional Cardiology Devices Branch, where he served as primary reviewer in the product areas of coronary stents, peripheral stents, and balloon angioplasty catheters.  While at FDA, he represented the Agency at numerous panel advisory meetings, scientific symposia, policy conferences, and voluntary standards development organization meetings.  He also provided consulting support and guidance in the areas of mechanical engineering, material science and medical device regulations to other FDA offices, U.S. governmental agencies, and international regulatory agencies.  For his efforts, he received both individual and group recognition awards from the Agency.

Dr. Oktay holds a considerable, in-depth understanding of the fields of material science, medical devices, medical device regulations, and regulatory submission requirements.  He has extensive experience interpreting and evaluating engineering data, developing and presenting reports of scientific review, and devising and modifying guidelines and protocols for the testing of medical devices.  He earned his doctoral degree in mechanical engineering from the University of Maryland, Baltimore County, his masterís degree in mechanical engineering from the University of Maryland, College Park, and his bachelorís degree in mechanical/manufacturing engineering from the Istanbul State Academy of Engineering and Architecture, Turkey.  He is currently an Adjunct Assistant Professor at the University of Maryland, Baltimore County, and his research interests are in coronary stents, balloon angioplasty, and the effects of balloon angioplasty on coronary arteries.

CONTACT DR. OKTAY

Office: (410) 674-2060

Fax: (410) 674-2133

Mobile: (410) 271-2088

Email: soktay@cardiomedllc.com

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